MAUDE Adverse Event Report: PENUMBRA, INC. APOLLO SYSTEM APOLLO WAND; GWG

Catalog Number AP9

Device Problem Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

The patient was undergoing a microneurosurgery procedure using an apollo system apollo wand.During the procedure, the apollo wand stopped aspirating clot.The wand was removed and the procedure continued using a new apollo wand.There was no report of an adverse effect on the patient.

Manufacturer Narrative

Conclusion: the device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Manufacturer Narrative

Result: there was no visible damage to the exterior of the apollo wand.Conclusion: the complaint has been evaluated.The complaint indicates that the apollo wand stopped working, possibly due to clogged clot within the lumen.The compliant also stated that vibration was not used often during the case.Evaluation of the returned product was confirmed.This type of issue normally occurs when vibration is not used during the procedure.If vibration is not applied during the entire usage of the apollo system, it is likely that clogging will occur.Stepping of the foot pedal while using the apollo system is what triggers the vibration inside the apollo wand and prevents clogging.The cause of this complaint could have been a user error.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: APOLLO SYSTEM APOLLO WAND
• Type of Device: GWG
• Manufacturer (Section D): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 4400603
• MDR Text Key: 5369816
• Report Number: 3005168196-2015-00018
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: AP9
• Device Lot Number: F45684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR